Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

A version of this article first appeared on Medscape.com.

Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

A version of this article first appeared on Medscape.com.

Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

A version of this article first appeared on Medscape.com.

Breast cancer recurrence rates are similar with anastrozole and tamoxifen in postmenopausal women with hormone receptor–positive ductal carcinoma in situ (HR-positive DCIS), according to long-term results of the IBIS-II DCIS trial.

“Our analysis shows that there was really no significant difference in recurrences,” said investigator Ivana Sestak, PhD, of Queen Mary University of London.

Similarly, there were no significant differences in overall deaths or breast cancer deaths. On the other hand, there were “clear differences” in adverse events with the two treatments, Dr. Sestak said.

“[W]e observed an excess of endometrial cancer and ovarian cancers in women who were randomized to tamoxifen and an excess of fractures, strokes, and transient ischemic attacks for women who were randomized to anastrozole,” Dr. Sestak said.

She presented these results at the 2020 San Antonio Breast Cancer Symposium.
 

Comparing IBIS-II DCIS with prior results

“The long-term results of the IBIS-II [DCIS] trial are consistent with previous results,” said Halle Moore, MD, of the Cleveland Clinic, who was not involved in this study.

However, the results do contrast with the findings of the NSABP-B35 study, “which demonstrated a very modest advantage to anastrozole that was mostly limited to younger postmenopausal women,” she said.

Indeed, a significant 27% reduction in recurrence was seen with anastrozole, compared with tamoxifen at a median of 9 years of follow-up in the NSABP-B35 study. But, as Dr. Sestak pointed out, that reduction “was mainly observed during the posttreatment follow-up period and not during the active treatment period.”

In the IBIS-II DCIS study, there was a nonsignificant 11% reduction in breast cancer recurrence with anastrozole.

The investigators did examine the potential effect of age on the rate of breast cancer recurrence, but no significant differences were found. They also looked at the active and post–endocrine therapy treatment periods, all showing no benefit of one drug over the other.

“So we clearly cannot replicate the findings of the NSABP-B35 study,” Dr. Sestak acknowledged.
 

IBIS-II DCIS details and results

Aromatase inhibitors such as anastrozole have been shown to be more effective than tamoxifen for preventing recurrence in postmenopausal HR+ women with invasive breast cancer, but it wasn’t previously known if this included women with HR-positive DCIS.

The IBIS-II DCIS study was therefore designed to determine if there was any advantage of anastrazole over tamoxifen. The phase 3 trial enrolled 2,980 postmenopausal women with HR-positive DCIS. They were randomized to 5 years of anastrozole or 5 years of tamoxifen.

“Women were followed up during this active period of treatment by clinic visits,” explained Dr. Sestak. “Thereafter, we collected data via questionnaire, registry data sets, and clinic visits.”

Baseline characteristics were similar between the treatment arms. The median age was about 60 years in both arms. Similar proportions of patients had received hormone replacement therapy (44.2% in the tamoxifen arm and 46.8% in the anastrozole arm) or undergone radiotherapy (71.5% and 70.9%, respectively).

Results showed little difference in breast cancer recurrence rates. At a median follow-up of 11.6 years, the rate of recurrence was 9.7% with tamoxifen and 8.5% with anastrozole (hazard ratio, 0.89; P = .401).

Trends were seen favoring anastrozole in estrogen receptor–positive and HER2-negative women, but this was only while women were being actively treated.

Death rates were similar – 4.2% with anastrozole and 4.5% with tamoxifen (odds ratio, 0.93). There were three breast cancer deaths in each treatment arm.
 

Adverse events could be the deciding factor

“The main take-away from this presentation is that choice of adjuvant endocrine therapy for DCIS should be individualized based primarily on the different side effect profiles of the two medications,” Dr. Moore said.

During the trial, “a significant 34% increase in fractures was observed in women who received anastrozole, compared to tamoxifen [HR, 1.34; P = .013],” Dr. Sestak said.

“We also observed a threefold increase in strokes and transient ischemic attacks with anastrozole, compared to tamoxifen [HR, 3.10; P = .021 for both strokes and transient ischemic attacks],” Dr. Sestak added.

She acknowledged that this finding is inconsistent with what is known about aromatase inhibitors in general. It could be that, rather than anastrozole raising the risk of strokes and transient ischemic attacks, tamoxifen was having a beneficial effect. This could be a result of tamoxifen improving endothelial function by increasing vasodilation, “but it is really not clear what the mechanism is,” Dr. Sestak said.

Also contrary to what is known about tamoxifen was an excess of deaths because of endometrial cancer or ovarian cancers. Wherever possible, the pathology reports had been requested to confirm the cause of death, “so we are pretty sure that they are true ovarian cancers and not some other abdominal tumors,” Dr. Sestak said.

“We did observe very clear differences in terms of adverse events,” she said, adding that “improved understanding of adverse event profiles will help patients with HR-positive DCIS to make an informed decision regarding their treatment.”

The IBIS-II DCIS trial was funded by Cancer Research UK, the National Health and Medical Research Council Australia, Breast Cancer Research Foundation, AstraZeneca, and Sanofi Aventis. Two investigators disclosed relationships with AstraZeneca, and one disclosed a relationship with Cancer Research UK. Dr. Sestak and Dr. Moore had no relevant disclosures.

SOURCE: Sestak I et al. SABCS 2020, Abstract GS2-02.

Breast cancer recurrence rates are similar with anastrozole and tamoxifen in postmenopausal women with hormone receptor–positive ductal carcinoma in situ (HR-positive DCIS), according to long-term results of the IBIS-II DCIS trial.

“Our analysis shows that there was really no significant difference in recurrences,” said investigator Ivana Sestak, PhD, of Queen Mary University of London.

Similarly, there were no significant differences in overall deaths or breast cancer deaths. On the other hand, there were “clear differences” in adverse events with the two treatments, Dr. Sestak said.

“[W]e observed an excess of endometrial cancer and ovarian cancers in women who were randomized to tamoxifen and an excess of fractures, strokes, and transient ischemic attacks for women who were randomized to anastrozole,” Dr. Sestak said.

She presented these results at the 2020 San Antonio Breast Cancer Symposium.
 

Comparing IBIS-II DCIS with prior results

“The long-term results of the IBIS-II [DCIS] trial are consistent with previous results,” said Halle Moore, MD, of the Cleveland Clinic, who was not involved in this study.

However, the results do contrast with the findings of the NSABP-B35 study, “which demonstrated a very modest advantage to anastrozole that was mostly limited to younger postmenopausal women,” she said.

Indeed, a significant 27% reduction in recurrence was seen with anastrozole, compared with tamoxifen at a median of 9 years of follow-up in the NSABP-B35 study. But, as Dr. Sestak pointed out, that reduction “was mainly observed during the posttreatment follow-up period and not during the active treatment period.”

In the IBIS-II DCIS study, there was a nonsignificant 11% reduction in breast cancer recurrence with anastrozole.

The investigators did examine the potential effect of age on the rate of breast cancer recurrence, but no significant differences were found. They also looked at the active and post–endocrine therapy treatment periods, all showing no benefit of one drug over the other.

“So we clearly cannot replicate the findings of the NSABP-B35 study,” Dr. Sestak acknowledged.
 

IBIS-II DCIS details and results

Aromatase inhibitors such as anastrozole have been shown to be more effective than tamoxifen for preventing recurrence in postmenopausal HR+ women with invasive breast cancer, but it wasn’t previously known if this included women with HR-positive DCIS.

The IBIS-II DCIS study was therefore designed to determine if there was any advantage of anastrazole over tamoxifen. The phase 3 trial enrolled 2,980 postmenopausal women with HR-positive DCIS. They were randomized to 5 years of anastrozole or 5 years of tamoxifen.

“Women were followed up during this active period of treatment by clinic visits,” explained Dr. Sestak. “Thereafter, we collected data via questionnaire, registry data sets, and clinic visits.”

Baseline characteristics were similar between the treatment arms. The median age was about 60 years in both arms. Similar proportions of patients had received hormone replacement therapy (44.2% in the tamoxifen arm and 46.8% in the anastrozole arm) or undergone radiotherapy (71.5% and 70.9%, respectively).

Results showed little difference in breast cancer recurrence rates. At a median follow-up of 11.6 years, the rate of recurrence was 9.7% with tamoxifen and 8.5% with anastrozole (hazard ratio, 0.89; P = .401).

Trends were seen favoring anastrozole in estrogen receptor–positive and HER2-negative women, but this was only while women were being actively treated.

Death rates were similar – 4.2% with anastrozole and 4.5% with tamoxifen (odds ratio, 0.93). There were three breast cancer deaths in each treatment arm.
 

Adverse events could be the deciding factor

“The main take-away from this presentation is that choice of adjuvant endocrine therapy for DCIS should be individualized based primarily on the different side effect profiles of the two medications,” Dr. Moore said.

During the trial, “a significant 34% increase in fractures was observed in women who received anastrozole, compared to tamoxifen [HR, 1.34; P = .013],” Dr. Sestak said.

“We also observed a threefold increase in strokes and transient ischemic attacks with anastrozole, compared to tamoxifen [HR, 3.10; P = .021 for both strokes and transient ischemic attacks],” Dr. Sestak added.

She acknowledged that this finding is inconsistent with what is known about aromatase inhibitors in general. It could be that, rather than anastrozole raising the risk of strokes and transient ischemic attacks, tamoxifen was having a beneficial effect. This could be a result of tamoxifen improving endothelial function by increasing vasodilation, “but it is really not clear what the mechanism is,” Dr. Sestak said.

Also contrary to what is known about tamoxifen was an excess of deaths because of endometrial cancer or ovarian cancers. Wherever possible, the pathology reports had been requested to confirm the cause of death, “so we are pretty sure that they are true ovarian cancers and not some other abdominal tumors,” Dr. Sestak said.

“We did observe very clear differences in terms of adverse events,” she said, adding that “improved understanding of adverse event profiles will help patients with HR-positive DCIS to make an informed decision regarding their treatment.”

The IBIS-II DCIS trial was funded by Cancer Research UK, the National Health and Medical Research Council Australia, Breast Cancer Research Foundation, AstraZeneca, and Sanofi Aventis. Two investigators disclosed relationships with AstraZeneca, and one disclosed a relationship with Cancer Research UK. Dr. Sestak and Dr. Moore had no relevant disclosures.

SOURCE: Sestak I et al. SABCS 2020, Abstract GS2-02.

Breast cancer recurrence rates are similar with anastrozole and tamoxifen in postmenopausal women with hormone receptor–positive ductal carcinoma in situ (HR-positive DCIS), according to long-term results of the IBIS-II DCIS trial.

“Our analysis shows that there was really no significant difference in recurrences,” said investigator Ivana Sestak, PhD, of Queen Mary University of London.

Similarly, there were no significant differences in overall deaths or breast cancer deaths. On the other hand, there were “clear differences” in adverse events with the two treatments, Dr. Sestak said.

“[W]e observed an excess of endometrial cancer and ovarian cancers in women who were randomized to tamoxifen and an excess of fractures, strokes, and transient ischemic attacks for women who were randomized to anastrozole,” Dr. Sestak said.

She presented these results at the 2020 San Antonio Breast Cancer Symposium.
 

Comparing IBIS-II DCIS with prior results

“The long-term results of the IBIS-II [DCIS] trial are consistent with previous results,” said Halle Moore, MD, of the Cleveland Clinic, who was not involved in this study.

However, the results do contrast with the findings of the NSABP-B35 study, “which demonstrated a very modest advantage to anastrozole that was mostly limited to younger postmenopausal women,” she said.

Indeed, a significant 27% reduction in recurrence was seen with anastrozole, compared with tamoxifen at a median of 9 years of follow-up in the NSABP-B35 study. But, as Dr. Sestak pointed out, that reduction “was mainly observed during the posttreatment follow-up period and not during the active treatment period.”

In the IBIS-II DCIS study, there was a nonsignificant 11% reduction in breast cancer recurrence with anastrozole.

The investigators did examine the potential effect of age on the rate of breast cancer recurrence, but no significant differences were found. They also looked at the active and post–endocrine therapy treatment periods, all showing no benefit of one drug over the other.

“So we clearly cannot replicate the findings of the NSABP-B35 study,” Dr. Sestak acknowledged.
 

IBIS-II DCIS details and results

Aromatase inhibitors such as anastrozole have been shown to be more effective than tamoxifen for preventing recurrence in postmenopausal HR+ women with invasive breast cancer, but it wasn’t previously known if this included women with HR-positive DCIS.

The IBIS-II DCIS study was therefore designed to determine if there was any advantage of anastrazole over tamoxifen. The phase 3 trial enrolled 2,980 postmenopausal women with HR-positive DCIS. They were randomized to 5 years of anastrozole or 5 years of tamoxifen.

“Women were followed up during this active period of treatment by clinic visits,” explained Dr. Sestak. “Thereafter, we collected data via questionnaire, registry data sets, and clinic visits.”

Baseline characteristics were similar between the treatment arms. The median age was about 60 years in both arms. Similar proportions of patients had received hormone replacement therapy (44.2% in the tamoxifen arm and 46.8% in the anastrozole arm) or undergone radiotherapy (71.5% and 70.9%, respectively).

Results showed little difference in breast cancer recurrence rates. At a median follow-up of 11.6 years, the rate of recurrence was 9.7% with tamoxifen and 8.5% with anastrozole (hazard ratio, 0.89; P = .401).

Trends were seen favoring anastrozole in estrogen receptor–positive and HER2-negative women, but this was only while women were being actively treated.

Death rates were similar – 4.2% with anastrozole and 4.5% with tamoxifen (odds ratio, 0.93). There were three breast cancer deaths in each treatment arm.
 

Adverse events could be the deciding factor

“The main take-away from this presentation is that choice of adjuvant endocrine therapy for DCIS should be individualized based primarily on the different side effect profiles of the two medications,” Dr. Moore said.

During the trial, “a significant 34% increase in fractures was observed in women who received anastrozole, compared to tamoxifen [HR, 1.34; P = .013],” Dr. Sestak said.

“We also observed a threefold increase in strokes and transient ischemic attacks with anastrozole, compared to tamoxifen [HR, 3.10; P = .021 for both strokes and transient ischemic attacks],” Dr. Sestak added.

She acknowledged that this finding is inconsistent with what is known about aromatase inhibitors in general. It could be that, rather than anastrozole raising the risk of strokes and transient ischemic attacks, tamoxifen was having a beneficial effect. This could be a result of tamoxifen improving endothelial function by increasing vasodilation, “but it is really not clear what the mechanism is,” Dr. Sestak said.

Also contrary to what is known about tamoxifen was an excess of deaths because of endometrial cancer or ovarian cancers. Wherever possible, the pathology reports had been requested to confirm the cause of death, “so we are pretty sure that they are true ovarian cancers and not some other abdominal tumors,” Dr. Sestak said.

“We did observe very clear differences in terms of adverse events,” she said, adding that “improved understanding of adverse event profiles will help patients with HR-positive DCIS to make an informed decision regarding their treatment.”

The IBIS-II DCIS trial was funded by Cancer Research UK, the National Health and Medical Research Council Australia, Breast Cancer Research Foundation, AstraZeneca, and Sanofi Aventis. Two investigators disclosed relationships with AstraZeneca, and one disclosed a relationship with Cancer Research UK. Dr. Sestak and Dr. Moore had no relevant disclosures.

SOURCE: Sestak I et al. SABCS 2020, Abstract GS2-02.

Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.

In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.

Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.

“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.

The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
 

SMA vs. group therapy

SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.

“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.

“While SMAs and group therapy seem similar, using the terms interchangeably would be incorrect given the differences in the type of care each group provides,” she added.

Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.

For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.

They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.

Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).

Most of the participants agreed or strongly agreed with the following statements:

• Scheduling appointments for SMAs is easy.
• I gain valuable information from the responses to other patients’ questions in SMAs.
• There is enough time for questions during SMAs.
• I gain valuable information from the doctor and social worker in SMAs.
• My medical needs are met during SMAs.
• I would recommend an SMA to other patients.
• Since starting SMAs, I find it easier to stick to my treatment plan.
• I have a lot of support outside of SMAs.
• People in SMAs give me the support I need to stick to my treatment plan.

Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.

Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
 

Bridging the gap

In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.

“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.

Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.

“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.

“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.

David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.

“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.

“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.

Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.

However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.

Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.

In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.

Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.

“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.

The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
 

SMA vs. group therapy

SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.

“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.

“While SMAs and group therapy seem similar, using the terms interchangeably would be incorrect given the differences in the type of care each group provides,” she added.

Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.

For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.

They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.

Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).

Most of the participants agreed or strongly agreed with the following statements:

• Scheduling appointments for SMAs is easy.
• I gain valuable information from the responses to other patients’ questions in SMAs.
• There is enough time for questions during SMAs.
• I gain valuable information from the doctor and social worker in SMAs.
• My medical needs are met during SMAs.
• I would recommend an SMA to other patients.
• Since starting SMAs, I find it easier to stick to my treatment plan.
• I have a lot of support outside of SMAs.
• People in SMAs give me the support I need to stick to my treatment plan.

Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.

Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
 

Bridging the gap

In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.

“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.

Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.

“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.

“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.

David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.

“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.

“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.

Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.

However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.

Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.

In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.

Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.

“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.

The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
 

SMA vs. group therapy

SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.

“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.

“While SMAs and group therapy seem similar, using the terms interchangeably would be incorrect given the differences in the type of care each group provides,” she added.

Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.

For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.

They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.

Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).

Most of the participants agreed or strongly agreed with the following statements:

• Scheduling appointments for SMAs is easy.
• I gain valuable information from the responses to other patients’ questions in SMAs.
• There is enough time for questions during SMAs.
• I gain valuable information from the doctor and social worker in SMAs.
• My medical needs are met during SMAs.
• I would recommend an SMA to other patients.
• Since starting SMAs, I find it easier to stick to my treatment plan.
• I have a lot of support outside of SMAs.
• People in SMAs give me the support I need to stick to my treatment plan.

Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.

Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
 

Bridging the gap

In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.

“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.

Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.

“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.

“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.

David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.

“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.

“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.

Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.

However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.

Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Rare cancers comprise about 20% of all cancers in the United States and Europe, according to recent estimates, but patients with rare cancers are vastly underrepresented in clinical trials.

Recently, there has been a focus on immune checkpoint blockade (ICB) in common cancer types. Since several rare tumor types share similar biologic features with the more common tumors, there is a need to test ICB in rare tumors, particularly because remissions with ICB can be durable.

Enter the DART trial, a phase 2, single-arm study of combinatorial ICB with ipilimumab plus nivolumab in patients with unresectable or metastatic rare cancers.

Results from DART were recently presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting. Michael J. Wagner, MD, of the University of Washington, Seattle, reported results in patients with advanced or unresectable angiosarcoma, one of the rare tumor types included in DART.
 

About angiosarcomas

Angiosarcomas account for less than 3% of all adult soft-tissue sarcomas, according to a review published in The Lancet Oncology. Angiosarcomas may arise in any part of the body, especially the head and neck (27%), breast (19.7%), and extremities (15.3%). These cancers can be primary or secondary (i.e., associated with prior radiation therapy or chronic lymphedema).

Angiosarcomas are aggressive, difficult to treat, and confer high mortality. The tumors are responsive to chemotherapy, but responses are brief. The estimated 5-year survival rate for all patients with angiosarcoma, including those who present with localized disease, is 30%-40%.

According to Dr. Wagner, a subset of angiosarcomas are characterized by high tumor mutational burden (TMB) and COSMIC signature 7, a DNA mutational signature that is consistent with other cancers caused by ultraviolet light exposure.

The high TMB subset of angiosarcomas is comparable with other cancer types that are responsive to ICB. Indeed, patients with angiosarcoma treated with ICB have shown responses, according to research published in the Journal for Immunotherapy of Cancer. However, no prospective studies of ICB in angiosarcoma have been published.
 

About DART

The DART trial includes more than 50 cohorts of rare cancer subtypes. Patients receive IV ipilimumab at 1 mg/kg every 6 weeks and IV nivolumab at 240 mg every 2 weeks.

The primary endpoint is objective response rate, as assessed by RECIST v1.1. Secondary endpoints include progression-free survival, overall survival, stable disease at 6 months, and toxicity.

The trial has a two-stage design. Six patients are enrolled in the first stage, and, if at least one patient responds to treatment, an additional 10 patients are enrolled in the second stage.

If at least two responses are seen among the 16 patients enrolled, further study of ICB is considered warranted.
 

Results in angiosarcoma

Dr. Wagner reported on the 16 angiosarcoma patients enrolled in DART. Nine patients had cutaneous primary tumors, seven had noncutaneous primary tumors, and three patients had radiation-associated angiosarcoma of the breast or chest wall.

Patients had received a median of two (range, zero to five) prior lines of therapy.

Adverse events (AEs) were consistent with prior safety results of the ipilimumab-nivolumab combination. Three-quarters of patients experienced an AE of any grade. The most common AEs were transaminase elevation, anemia, diarrhea, fatigue, hypothyroidism, pneumonitis, pruritus, and rash.

A quarter of patients had a grade 3-4 AE, and 12.5% of AEs led to premature treatment discontinuation. There were no fatal AEs.

The ORR was 25%. Responses occurred in 4 of the 16 patients, including 3 of 5 patients with primary cutaneous tumors of the scalp or face and 1 of 3 patients with radiation-associated breast angiosarcoma.

Two of the four responses and one case of stable disease have persisted for almost a year, and these patients remain on treatment. To put these results into perspective, Dr. Wagner noted that responses to cytotoxic chemotherapy rarely last 6 months.

The 6-month progression-free survival rate was 38%. The median overall survival has not yet been reached.

Dr. Wagner concluded that the combinatorial ICB regimen employed in DART was well tolerated and had an ORR of 25% in angiosarcoma regardless of primary site. Per the criteria of the DART trial, further investigation of ICB in angiosarcoma is warranted.
 

Molecular insights

Although correlative analyses of tumor tissue and peripheral blood are embedded in the DART trial, those analyses have not yet been performed. Eight of the 16 angiosarcoma patients had diagnostic molecular studies performed at their parent institutions, utilizing a variety of commercial platforms.

All eight patients for whom molecular data were available had at least two deleterious genomic alterations detected, but each had a distinct molecular profile.

Seven patients had TMB analyzed, including two partial responders to ICB. One of the seven patients had a high TMB, and this patient was one of the two responders. The other responder had an intermediate TMB.

Three patients had programmed death–ligand 1 staining on their tumors. Two of the three had high expression of PD-L1, including the responder with an intermediate TMB.
 

The real impact of DART

The DART trial is a “basket trial,” employing a similar treatment regimen for multiple tumor types. It provides a uniform framework for studying tumors that have been neglected in clinical trials heretofore.

Although the cohort of angiosarcoma patients is small, central pathology review was not required, and the treatment regimen was not compared directly with other potential therapies, the reported results of the ipilimumab-nivolumab regimen justify further study.

The biospecimens collected in DART will provide a rich source of data to identify common themes among responders and nonresponders, among patients who experience durable remissions and those who do not.

Angiosarcoma is not the only rare cancer for which combinatorial ICB has been valuable under the auspices of the DART trial. In Clinical Cancer Research, investigators reported an ORR of 44% among patients with high-grade neuroendocrine cancers, independent of primary site of origin. Progression-free survival at 6 months was 31%.

The DART trial is available at more than 800 sites, providing access to potentially promising treatment in a rigorous, scientifically valuable study for geographically underserved populations, including patients who live in rural areas.

The key message for practicing oncologists and clinical investigators is that clinical trials in rare tumors are feasible and can yield hope for patients who might lack it otherwise.

DART is funded by the National Cancer Institute and Bristol-Myers Squibb. Dr. Wagner disclosed relationships with Deciphera, Adaptimmune, GlaxoSmithKline, Athenex, and Incyte.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Wagner M et al. SITC 2020, Abstract 795.

Rare cancers comprise about 20% of all cancers in the United States and Europe, according to recent estimates, but patients with rare cancers are vastly underrepresented in clinical trials.

Recently, there has been a focus on immune checkpoint blockade (ICB) in common cancer types. Since several rare tumor types share similar biologic features with the more common tumors, there is a need to test ICB in rare tumors, particularly because remissions with ICB can be durable.

Enter the DART trial, a phase 2, single-arm study of combinatorial ICB with ipilimumab plus nivolumab in patients with unresectable or metastatic rare cancers.

Results from DART were recently presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting. Michael J. Wagner, MD, of the University of Washington, Seattle, reported results in patients with advanced or unresectable angiosarcoma, one of the rare tumor types included in DART.
 

About angiosarcomas

Angiosarcomas account for less than 3% of all adult soft-tissue sarcomas, according to a review published in The Lancet Oncology. Angiosarcomas may arise in any part of the body, especially the head and neck (27%), breast (19.7%), and extremities (15.3%). These cancers can be primary or secondary (i.e., associated with prior radiation therapy or chronic lymphedema).

Angiosarcomas are aggressive, difficult to treat, and confer high mortality. The tumors are responsive to chemotherapy, but responses are brief. The estimated 5-year survival rate for all patients with angiosarcoma, including those who present with localized disease, is 30%-40%.

According to Dr. Wagner, a subset of angiosarcomas are characterized by high tumor mutational burden (TMB) and COSMIC signature 7, a DNA mutational signature that is consistent with other cancers caused by ultraviolet light exposure.

The high TMB subset of angiosarcomas is comparable with other cancer types that are responsive to ICB. Indeed, patients with angiosarcoma treated with ICB have shown responses, according to research published in the Journal for Immunotherapy of Cancer. However, no prospective studies of ICB in angiosarcoma have been published.
 

About DART

The DART trial includes more than 50 cohorts of rare cancer subtypes. Patients receive IV ipilimumab at 1 mg/kg every 6 weeks and IV nivolumab at 240 mg every 2 weeks.

The primary endpoint is objective response rate, as assessed by RECIST v1.1. Secondary endpoints include progression-free survival, overall survival, stable disease at 6 months, and toxicity.

The trial has a two-stage design. Six patients are enrolled in the first stage, and, if at least one patient responds to treatment, an additional 10 patients are enrolled in the second stage.

If at least two responses are seen among the 16 patients enrolled, further study of ICB is considered warranted.
 

Results in angiosarcoma

Dr. Wagner reported on the 16 angiosarcoma patients enrolled in DART. Nine patients had cutaneous primary tumors, seven had noncutaneous primary tumors, and three patients had radiation-associated angiosarcoma of the breast or chest wall.

Patients had received a median of two (range, zero to five) prior lines of therapy.

Adverse events (AEs) were consistent with prior safety results of the ipilimumab-nivolumab combination. Three-quarters of patients experienced an AE of any grade. The most common AEs were transaminase elevation, anemia, diarrhea, fatigue, hypothyroidism, pneumonitis, pruritus, and rash.

A quarter of patients had a grade 3-4 AE, and 12.5% of AEs led to premature treatment discontinuation. There were no fatal AEs.

The ORR was 25%. Responses occurred in 4 of the 16 patients, including 3 of 5 patients with primary cutaneous tumors of the scalp or face and 1 of 3 patients with radiation-associated breast angiosarcoma.

Two of the four responses and one case of stable disease have persisted for almost a year, and these patients remain on treatment. To put these results into perspective, Dr. Wagner noted that responses to cytotoxic chemotherapy rarely last 6 months.

The 6-month progression-free survival rate was 38%. The median overall survival has not yet been reached.

Dr. Wagner concluded that the combinatorial ICB regimen employed in DART was well tolerated and had an ORR of 25% in angiosarcoma regardless of primary site. Per the criteria of the DART trial, further investigation of ICB in angiosarcoma is warranted.
 

Molecular insights

Although correlative analyses of tumor tissue and peripheral blood are embedded in the DART trial, those analyses have not yet been performed. Eight of the 16 angiosarcoma patients had diagnostic molecular studies performed at their parent institutions, utilizing a variety of commercial platforms.

All eight patients for whom molecular data were available had at least two deleterious genomic alterations detected, but each had a distinct molecular profile.

Seven patients had TMB analyzed, including two partial responders to ICB. One of the seven patients had a high TMB, and this patient was one of the two responders. The other responder had an intermediate TMB.

Three patients had programmed death–ligand 1 staining on their tumors. Two of the three had high expression of PD-L1, including the responder with an intermediate TMB.
 

The real impact of DART

The DART trial is a “basket trial,” employing a similar treatment regimen for multiple tumor types. It provides a uniform framework for studying tumors that have been neglected in clinical trials heretofore.

Although the cohort of angiosarcoma patients is small, central pathology review was not required, and the treatment regimen was not compared directly with other potential therapies, the reported results of the ipilimumab-nivolumab regimen justify further study.

The biospecimens collected in DART will provide a rich source of data to identify common themes among responders and nonresponders, among patients who experience durable remissions and those who do not.

Angiosarcoma is not the only rare cancer for which combinatorial ICB has been valuable under the auspices of the DART trial. In Clinical Cancer Research, investigators reported an ORR of 44% among patients with high-grade neuroendocrine cancers, independent of primary site of origin. Progression-free survival at 6 months was 31%.

The DART trial is available at more than 800 sites, providing access to potentially promising treatment in a rigorous, scientifically valuable study for geographically underserved populations, including patients who live in rural areas.

The key message for practicing oncologists and clinical investigators is that clinical trials in rare tumors are feasible and can yield hope for patients who might lack it otherwise.

DART is funded by the National Cancer Institute and Bristol-Myers Squibb. Dr. Wagner disclosed relationships with Deciphera, Adaptimmune, GlaxoSmithKline, Athenex, and Incyte.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Wagner M et al. SITC 2020, Abstract 795.

Rare cancers comprise about 20% of all cancers in the United States and Europe, according to recent estimates, but patients with rare cancers are vastly underrepresented in clinical trials.

Recently, there has been a focus on immune checkpoint blockade (ICB) in common cancer types. Since several rare tumor types share similar biologic features with the more common tumors, there is a need to test ICB in rare tumors, particularly because remissions with ICB can be durable.

Enter the DART trial, a phase 2, single-arm study of combinatorial ICB with ipilimumab plus nivolumab in patients with unresectable or metastatic rare cancers.

Results from DART were recently presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting. Michael J. Wagner, MD, of the University of Washington, Seattle, reported results in patients with advanced or unresectable angiosarcoma, one of the rare tumor types included in DART.
 

About angiosarcomas

Angiosarcomas account for less than 3% of all adult soft-tissue sarcomas, according to a review published in The Lancet Oncology. Angiosarcomas may arise in any part of the body, especially the head and neck (27%), breast (19.7%), and extremities (15.3%). These cancers can be primary or secondary (i.e., associated with prior radiation therapy or chronic lymphedema).

Angiosarcomas are aggressive, difficult to treat, and confer high mortality. The tumors are responsive to chemotherapy, but responses are brief. The estimated 5-year survival rate for all patients with angiosarcoma, including those who present with localized disease, is 30%-40%.

According to Dr. Wagner, a subset of angiosarcomas are characterized by high tumor mutational burden (TMB) and COSMIC signature 7, a DNA mutational signature that is consistent with other cancers caused by ultraviolet light exposure.

The high TMB subset of angiosarcomas is comparable with other cancer types that are responsive to ICB. Indeed, patients with angiosarcoma treated with ICB have shown responses, according to research published in the Journal for Immunotherapy of Cancer. However, no prospective studies of ICB in angiosarcoma have been published.
 

About DART

The DART trial includes more than 50 cohorts of rare cancer subtypes. Patients receive IV ipilimumab at 1 mg/kg every 6 weeks and IV nivolumab at 240 mg every 2 weeks.

The primary endpoint is objective response rate, as assessed by RECIST v1.1. Secondary endpoints include progression-free survival, overall survival, stable disease at 6 months, and toxicity.

The trial has a two-stage design. Six patients are enrolled in the first stage, and, if at least one patient responds to treatment, an additional 10 patients are enrolled in the second stage.

If at least two responses are seen among the 16 patients enrolled, further study of ICB is considered warranted.
 

Results in angiosarcoma

Dr. Wagner reported on the 16 angiosarcoma patients enrolled in DART. Nine patients had cutaneous primary tumors, seven had noncutaneous primary tumors, and three patients had radiation-associated angiosarcoma of the breast or chest wall.

Patients had received a median of two (range, zero to five) prior lines of therapy.

Adverse events (AEs) were consistent with prior safety results of the ipilimumab-nivolumab combination. Three-quarters of patients experienced an AE of any grade. The most common AEs were transaminase elevation, anemia, diarrhea, fatigue, hypothyroidism, pneumonitis, pruritus, and rash.

A quarter of patients had a grade 3-4 AE, and 12.5% of AEs led to premature treatment discontinuation. There were no fatal AEs.

The ORR was 25%. Responses occurred in 4 of the 16 patients, including 3 of 5 patients with primary cutaneous tumors of the scalp or face and 1 of 3 patients with radiation-associated breast angiosarcoma.

Two of the four responses and one case of stable disease have persisted for almost a year, and these patients remain on treatment. To put these results into perspective, Dr. Wagner noted that responses to cytotoxic chemotherapy rarely last 6 months.

The 6-month progression-free survival rate was 38%. The median overall survival has not yet been reached.

Dr. Wagner concluded that the combinatorial ICB regimen employed in DART was well tolerated and had an ORR of 25% in angiosarcoma regardless of primary site. Per the criteria of the DART trial, further investigation of ICB in angiosarcoma is warranted.
 

Molecular insights

Although correlative analyses of tumor tissue and peripheral blood are embedded in the DART trial, those analyses have not yet been performed. Eight of the 16 angiosarcoma patients had diagnostic molecular studies performed at their parent institutions, utilizing a variety of commercial platforms.

All eight patients for whom molecular data were available had at least two deleterious genomic alterations detected, but each had a distinct molecular profile.

Seven patients had TMB analyzed, including two partial responders to ICB. One of the seven patients had a high TMB, and this patient was one of the two responders. The other responder had an intermediate TMB.

Three patients had programmed death–ligand 1 staining on their tumors. Two of the three had high expression of PD-L1, including the responder with an intermediate TMB.
 

The real impact of DART

The DART trial is a “basket trial,” employing a similar treatment regimen for multiple tumor types. It provides a uniform framework for studying tumors that have been neglected in clinical trials heretofore.

Although the cohort of angiosarcoma patients is small, central pathology review was not required, and the treatment regimen was not compared directly with other potential therapies, the reported results of the ipilimumab-nivolumab regimen justify further study.

The biospecimens collected in DART will provide a rich source of data to identify common themes among responders and nonresponders, among patients who experience durable remissions and those who do not.

Angiosarcoma is not the only rare cancer for which combinatorial ICB has been valuable under the auspices of the DART trial. In Clinical Cancer Research, investigators reported an ORR of 44% among patients with high-grade neuroendocrine cancers, independent of primary site of origin. Progression-free survival at 6 months was 31%.

The DART trial is available at more than 800 sites, providing access to potentially promising treatment in a rigorous, scientifically valuable study for geographically underserved populations, including patients who live in rural areas.

The key message for practicing oncologists and clinical investigators is that clinical trials in rare tumors are feasible and can yield hope for patients who might lack it otherwise.

DART is funded by the National Cancer Institute and Bristol-Myers Squibb. Dr. Wagner disclosed relationships with Deciphera, Adaptimmune, GlaxoSmithKline, Athenex, and Incyte.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Wagner M et al. SITC 2020, Abstract 795.

After infection with SARS-CoV-2, antibodies protect most health care workers from reinfection for up to 6 months, results of the first prospective study of the subject revealed.

Courtesy NIAID-RML

The main message for health care workers is, “if you’ve had COVID, at least in the short term, you are unlikely to get it again,” David Eyre, DPhil, senior author, associate professor at the Big Data Institute and infectious diseases clinician at the University of Oxford (England), said in an interview.

Dr. Eyre and colleagues assessed for the presence of two antibodies to SARS-CoV-2 among 12,541 health care workers in the United Kingdom, including about 10% who had a history of polymerase chain reaction (PCR)–confirmed infection. Of those, 223 who did not have antibodies tested positive on PCR for the virus during 31 weeks of follow-up; two participants who did not have antibodies at baseline tested positive.

The study was published online Dec. 23 in The New England Journal of Medicine.

“It’s great news because there have been so many questions regarding whether or not you can be protected against reinfection, and this health care worker study is really an elegant way to address that question,” Mark Slifka, PhD, said in an interview when asked to comment on the findings.

Although “there are millions of people in the U.S. who have been infected with COVID, we don’t know how common reinfection is,” said Dr. Slifka, a researcher at the Oregon National Primate Research Center and professor at Oregon Health & Science University, Portland.

The likelihood of a subsequent positive PCR test result was 1.09 per 10,000 days at risk among those without antibodies, compared with 0.13 per 10,000 days among those with anti-spike antibodies.

The investigators also assessed for the presence of anti–nucleocapsid IgG antibody titers. They found a significant trend for increasing PCR-positive test results with increasing antibody levels. As with the anti-spike antibody findings, 226 of 11,543 health care providers who did not have anti–nucleocapsid IgG antibodies subsequently tested positive on PCR; by contrast, two of 1,172 participants who did not have antibodies tested positive. Adjusted for age, sex, and calendar time, this finding translates to a 0.11 incidence rate ratio (0.13 per 10,000 days at risk; 95% confidence interval, 0.03-0.45; P = .002).

“This is a study a number of us have been trying to do,” said Christopher L. King, MD, PhD, professor of pathology and associate professor of medicine at Case Western Reserve University, Cleveland.

“To really follow a group like this longitudinally like they’ve done, with a large population, and to see such a big difference – it really confirms our suspicion that those who do become infected and develop an antibody response are significantly protected from reinfection.

“What’s great about this study is it’s nearly a 10-fold reduction in risk if you’ve recovered from COVID and have antibodies,” said Dr. King, who was not involved with the research. “That’s what a lot of us have been wanting to know.”
 

Unanswered questions remain

“How long this immunity lasts, we don’t know,” Dr. King said. He predicted that antibody protection could last a year to a year and a half. The duration of protection could vary. “We know some people lose their antibodies pretty quickly, and other people don’t,” he said.

Dr. Slifka said the suggestion of “a substantially reduced risk for at least 6 months ... is great news, and the timing couldn’t be better, because we’re rolling out the vaccines.”

Not all antibody responses are alike. For example, data indicate that antibody levels following immunization with the Pfizer/BioNTech or Moderna vaccines are higher on average than those of people who’ve had a natural infection, Dr. King said. He added that initial data on the AstraZeneca COVID-19 vaccine in development showed lower antibody levels compared with natural immunity.

The Centers for Disease Control and Prevention recommends immunization for those with a history of infection. “People who have gotten sick with COVID-19 may still benefit from getting vaccinated,” the CDC notes on its Facts About COVID-19 Vaccines website. “Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before,” the CDC stated.

The agency also notes that people appear to become susceptible to reinfection approximately 90 days after onset of infection. However, the new evidence from the UK study that persons have up to 6 months of immune protection might lead to a modification of recommendations, especially at a time when vaccine supplies are limited, Dr. Slifka said.

Another unanswered question is why the two study participants with antibodies subsequently tested positive for reinfection. “There are a lot of things that could have made these people more susceptible,” Dr. King said. For example, they could have been heavily exposed to SARS-CoV-2 or been immunocompromised for another reason.

Furthermore, the immune response involves more than antibody levels, Dr. King noted. Research in rhesus monkeys suggests that T cells play a role, but not as prominent a part as antibodies. “What I think is protecting us from infection is primarily the antibodies, although the T cells are probably important. Once you get infected, the T cells are probably playing a more important role in terms of whether you get very sick or not,” he said.
 

Multiplication + addition = more protected?

The 90% natural immunity protection in the study approaches the 95% efficacy associated with the Pfizer and Moderna vaccines, Dr. Slifka noted. Even without immunization, this could mean a portion of the U.S. population is already protected against future infection.

Furthermore, the CDC estimates that there are about 7.7 cases of COVID-19 for every case reported.

As of Sept. 30, the CDC reported that there were 6,891,764 confirmed cases. The agency estimated that overall, approximately 53 million people in the United States have been infected. More recent numbers from Johns Hopkins University’s Coronavirus Resource Center indicate that there were 18.2 million cases in the United States as of Dec. 22. If that tally is multiplied by 7.7, the total number protected could approach 140 million, Dr. Slifka said.

“That could really be a boost in terms of knocking this pandemic down in the next couple of months,” Dr. Slifka said.

“Now, if we were to modify the current recommendations and briefly defer vaccination of people with confirmed cases of COVID-19 until later on, we could start reaching herd immunity pretty quickly,” he added.
 

Real-life implications

“There is no such thing as 100% protection, even from the infection itself. So when you’re dealing with someone with possible exposure to COVID-19, you still need to follow the proper precautions,” Dr. Slifka said.

Nonetheless, he said, “This is great news for those on the front lines who are wondering whether or not they would have any protection if they had COVID-19 before. And the answer is yes – there is a very good chance they will have protection, based on this quite large study.”

One limitation of the study is that the population consisted predominantly of healthy adult health care workers aged 65 years or younger. “Further studies are needed to assess postinfection immunity in other populations, including children, older adults, and persons with coexisting conditions, including immunosuppression,” the researchers noted.

Dr. Eyre plans to continue following the health care workers in the study, some of whom have been vaccinated for COVID-19. This ongoing research will allow him and coinvestigators to “confirm the protection offered by vaccination and investigate how postvaccine antibody responses vary by whether you have had COVID-19 before or not. We also want to understand more about how long postinfection immunity lasts.”

Dr. Eyre has received grants as a Robinson Foundation Fellow and NIHR Oxford BRC senior fellow during the conduct of the study. Dr. Slifka and Dr. King report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After infection with SARS-CoV-2, antibodies protect most health care workers from reinfection for up to 6 months, results of the first prospective study of the subject revealed.

Courtesy NIAID-RML

The main message for health care workers is, “if you’ve had COVID, at least in the short term, you are unlikely to get it again,” David Eyre, DPhil, senior author, associate professor at the Big Data Institute and infectious diseases clinician at the University of Oxford (England), said in an interview.

Dr. Eyre and colleagues assessed for the presence of two antibodies to SARS-CoV-2 among 12,541 health care workers in the United Kingdom, including about 10% who had a history of polymerase chain reaction (PCR)–confirmed infection. Of those, 223 who did not have antibodies tested positive on PCR for the virus during 31 weeks of follow-up; two participants who did not have antibodies at baseline tested positive.

The study was published online Dec. 23 in The New England Journal of Medicine.

“It’s great news because there have been so many questions regarding whether or not you can be protected against reinfection, and this health care worker study is really an elegant way to address that question,” Mark Slifka, PhD, said in an interview when asked to comment on the findings.

Although “there are millions of people in the U.S. who have been infected with COVID, we don’t know how common reinfection is,” said Dr. Slifka, a researcher at the Oregon National Primate Research Center and professor at Oregon Health & Science University, Portland.

The likelihood of a subsequent positive PCR test result was 1.09 per 10,000 days at risk among those without antibodies, compared with 0.13 per 10,000 days among those with anti-spike antibodies.

The investigators also assessed for the presence of anti–nucleocapsid IgG antibody titers. They found a significant trend for increasing PCR-positive test results with increasing antibody levels. As with the anti-spike antibody findings, 226 of 11,543 health care providers who did not have anti–nucleocapsid IgG antibodies subsequently tested positive on PCR; by contrast, two of 1,172 participants who did not have antibodies tested positive. Adjusted for age, sex, and calendar time, this finding translates to a 0.11 incidence rate ratio (0.13 per 10,000 days at risk; 95% confidence interval, 0.03-0.45; P = .002).

“This is a study a number of us have been trying to do,” said Christopher L. King, MD, PhD, professor of pathology and associate professor of medicine at Case Western Reserve University, Cleveland.

“To really follow a group like this longitudinally like they’ve done, with a large population, and to see such a big difference – it really confirms our suspicion that those who do become infected and develop an antibody response are significantly protected from reinfection.

“What’s great about this study is it’s nearly a 10-fold reduction in risk if you’ve recovered from COVID and have antibodies,” said Dr. King, who was not involved with the research. “That’s what a lot of us have been wanting to know.”
 

Unanswered questions remain

“How long this immunity lasts, we don’t know,” Dr. King said. He predicted that antibody protection could last a year to a year and a half. The duration of protection could vary. “We know some people lose their antibodies pretty quickly, and other people don’t,” he said.

Dr. Slifka said the suggestion of “a substantially reduced risk for at least 6 months ... is great news, and the timing couldn’t be better, because we’re rolling out the vaccines.”

Not all antibody responses are alike. For example, data indicate that antibody levels following immunization with the Pfizer/BioNTech or Moderna vaccines are higher on average than those of people who’ve had a natural infection, Dr. King said. He added that initial data on the AstraZeneca COVID-19 vaccine in development showed lower antibody levels compared with natural immunity.

The Centers for Disease Control and Prevention recommends immunization for those with a history of infection. “People who have gotten sick with COVID-19 may still benefit from getting vaccinated,” the CDC notes on its Facts About COVID-19 Vaccines website. “Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before,” the CDC stated.

The agency also notes that people appear to become susceptible to reinfection approximately 90 days after onset of infection. However, the new evidence from the UK study that persons have up to 6 months of immune protection might lead to a modification of recommendations, especially at a time when vaccine supplies are limited, Dr. Slifka said.

Another unanswered question is why the two study participants with antibodies subsequently tested positive for reinfection. “There are a lot of things that could have made these people more susceptible,” Dr. King said. For example, they could have been heavily exposed to SARS-CoV-2 or been immunocompromised for another reason.

Furthermore, the immune response involves more than antibody levels, Dr. King noted. Research in rhesus monkeys suggests that T cells play a role, but not as prominent a part as antibodies. “What I think is protecting us from infection is primarily the antibodies, although the T cells are probably important. Once you get infected, the T cells are probably playing a more important role in terms of whether you get very sick or not,” he said.
 

Multiplication + addition = more protected?

The 90% natural immunity protection in the study approaches the 95% efficacy associated with the Pfizer and Moderna vaccines, Dr. Slifka noted. Even without immunization, this could mean a portion of the U.S. population is already protected against future infection.

Furthermore, the CDC estimates that there are about 7.7 cases of COVID-19 for every case reported.

As of Sept. 30, the CDC reported that there were 6,891,764 confirmed cases. The agency estimated that overall, approximately 53 million people in the United States have been infected. More recent numbers from Johns Hopkins University’s Coronavirus Resource Center indicate that there were 18.2 million cases in the United States as of Dec. 22. If that tally is multiplied by 7.7, the total number protected could approach 140 million, Dr. Slifka said.

“That could really be a boost in terms of knocking this pandemic down in the next couple of months,” Dr. Slifka said.

“Now, if we were to modify the current recommendations and briefly defer vaccination of people with confirmed cases of COVID-19 until later on, we could start reaching herd immunity pretty quickly,” he added.
 

Real-life implications

“There is no such thing as 100% protection, even from the infection itself. So when you’re dealing with someone with possible exposure to COVID-19, you still need to follow the proper precautions,” Dr. Slifka said.

Nonetheless, he said, “This is great news for those on the front lines who are wondering whether or not they would have any protection if they had COVID-19 before. And the answer is yes – there is a very good chance they will have protection, based on this quite large study.”

One limitation of the study is that the population consisted predominantly of healthy adult health care workers aged 65 years or younger. “Further studies are needed to assess postinfection immunity in other populations, including children, older adults, and persons with coexisting conditions, including immunosuppression,” the researchers noted.

Dr. Eyre plans to continue following the health care workers in the study, some of whom have been vaccinated for COVID-19. This ongoing research will allow him and coinvestigators to “confirm the protection offered by vaccination and investigate how postvaccine antibody responses vary by whether you have had COVID-19 before or not. We also want to understand more about how long postinfection immunity lasts.”

Dr. Eyre has received grants as a Robinson Foundation Fellow and NIHR Oxford BRC senior fellow during the conduct of the study. Dr. Slifka and Dr. King report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After infection with SARS-CoV-2, antibodies protect most health care workers from reinfection for up to 6 months, results of the first prospective study of the subject revealed.

Courtesy NIAID-RML

The main message for health care workers is, “if you’ve had COVID, at least in the short term, you are unlikely to get it again,” David Eyre, DPhil, senior author, associate professor at the Big Data Institute and infectious diseases clinician at the University of Oxford (England), said in an interview.

Dr. Eyre and colleagues assessed for the presence of two antibodies to SARS-CoV-2 among 12,541 health care workers in the United Kingdom, including about 10% who had a history of polymerase chain reaction (PCR)–confirmed infection. Of those, 223 who did not have antibodies tested positive on PCR for the virus during 31 weeks of follow-up; two participants who did not have antibodies at baseline tested positive.

The study was published online Dec. 23 in The New England Journal of Medicine.

“It’s great news because there have been so many questions regarding whether or not you can be protected against reinfection, and this health care worker study is really an elegant way to address that question,” Mark Slifka, PhD, said in an interview when asked to comment on the findings.

Although “there are millions of people in the U.S. who have been infected with COVID, we don’t know how common reinfection is,” said Dr. Slifka, a researcher at the Oregon National Primate Research Center and professor at Oregon Health & Science University, Portland.

The likelihood of a subsequent positive PCR test result was 1.09 per 10,000 days at risk among those without antibodies, compared with 0.13 per 10,000 days among those with anti-spike antibodies.

The investigators also assessed for the presence of anti–nucleocapsid IgG antibody titers. They found a significant trend for increasing PCR-positive test results with increasing antibody levels. As with the anti-spike antibody findings, 226 of 11,543 health care providers who did not have anti–nucleocapsid IgG antibodies subsequently tested positive on PCR; by contrast, two of 1,172 participants who did not have antibodies tested positive. Adjusted for age, sex, and calendar time, this finding translates to a 0.11 incidence rate ratio (0.13 per 10,000 days at risk; 95% confidence interval, 0.03-0.45; P = .002).

“This is a study a number of us have been trying to do,” said Christopher L. King, MD, PhD, professor of pathology and associate professor of medicine at Case Western Reserve University, Cleveland.

“To really follow a group like this longitudinally like they’ve done, with a large population, and to see such a big difference – it really confirms our suspicion that those who do become infected and develop an antibody response are significantly protected from reinfection.

“What’s great about this study is it’s nearly a 10-fold reduction in risk if you’ve recovered from COVID and have antibodies,” said Dr. King, who was not involved with the research. “That’s what a lot of us have been wanting to know.”
 

Unanswered questions remain

“How long this immunity lasts, we don’t know,” Dr. King said. He predicted that antibody protection could last a year to a year and a half. The duration of protection could vary. “We know some people lose their antibodies pretty quickly, and other people don’t,” he said.

Dr. Slifka said the suggestion of “a substantially reduced risk for at least 6 months ... is great news, and the timing couldn’t be better, because we’re rolling out the vaccines.”

Not all antibody responses are alike. For example, data indicate that antibody levels following immunization with the Pfizer/BioNTech or Moderna vaccines are higher on average than those of people who’ve had a natural infection, Dr. King said. He added that initial data on the AstraZeneca COVID-19 vaccine in development showed lower antibody levels compared with natural immunity.

The Centers for Disease Control and Prevention recommends immunization for those with a history of infection. “People who have gotten sick with COVID-19 may still benefit from getting vaccinated,” the CDC notes on its Facts About COVID-19 Vaccines website. “Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before,” the CDC stated.

The agency also notes that people appear to become susceptible to reinfection approximately 90 days after onset of infection. However, the new evidence from the UK study that persons have up to 6 months of immune protection might lead to a modification of recommendations, especially at a time when vaccine supplies are limited, Dr. Slifka said.

Another unanswered question is why the two study participants with antibodies subsequently tested positive for reinfection. “There are a lot of things that could have made these people more susceptible,” Dr. King said. For example, they could have been heavily exposed to SARS-CoV-2 or been immunocompromised for another reason.

Furthermore, the immune response involves more than antibody levels, Dr. King noted. Research in rhesus monkeys suggests that T cells play a role, but not as prominent a part as antibodies. “What I think is protecting us from infection is primarily the antibodies, although the T cells are probably important. Once you get infected, the T cells are probably playing a more important role in terms of whether you get very sick or not,” he said.
 

Multiplication + addition = more protected?

The 90% natural immunity protection in the study approaches the 95% efficacy associated with the Pfizer and Moderna vaccines, Dr. Slifka noted. Even without immunization, this could mean a portion of the U.S. population is already protected against future infection.

Furthermore, the CDC estimates that there are about 7.7 cases of COVID-19 for every case reported.

As of Sept. 30, the CDC reported that there were 6,891,764 confirmed cases. The agency estimated that overall, approximately 53 million people in the United States have been infected. More recent numbers from Johns Hopkins University’s Coronavirus Resource Center indicate that there were 18.2 million cases in the United States as of Dec. 22. If that tally is multiplied by 7.7, the total number protected could approach 140 million, Dr. Slifka said.

“That could really be a boost in terms of knocking this pandemic down in the next couple of months,” Dr. Slifka said.

“Now, if we were to modify the current recommendations and briefly defer vaccination of people with confirmed cases of COVID-19 until later on, we could start reaching herd immunity pretty quickly,” he added.
 

Real-life implications

“There is no such thing as 100% protection, even from the infection itself. So when you’re dealing with someone with possible exposure to COVID-19, you still need to follow the proper precautions,” Dr. Slifka said.

Nonetheless, he said, “This is great news for those on the front lines who are wondering whether or not they would have any protection if they had COVID-19 before. And the answer is yes – there is a very good chance they will have protection, based on this quite large study.”

One limitation of the study is that the population consisted predominantly of healthy adult health care workers aged 65 years or younger. “Further studies are needed to assess postinfection immunity in other populations, including children, older adults, and persons with coexisting conditions, including immunosuppression,” the researchers noted.

Dr. Eyre plans to continue following the health care workers in the study, some of whom have been vaccinated for COVID-19. This ongoing research will allow him and coinvestigators to “confirm the protection offered by vaccination and investigate how postvaccine antibody responses vary by whether you have had COVID-19 before or not. We also want to understand more about how long postinfection immunity lasts.”

Dr. Eyre has received grants as a Robinson Foundation Fellow and NIHR Oxford BRC senior fellow during the conduct of the study. Dr. Slifka and Dr. King report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

During a particularly hectic day, Janeni Nayagan, MD, a first-year resident in the department of psychiatry and behavioral health at Cooper University Hospital, Camden, N.J., was taken aback – but not surprised – by a patient’s comment.

In the middle of an emergent situation, she overheard a patient say that Dr. Nayagan wasn’t a “real doctor, she’s a psych doctor.”

“When it happened, I wasn’t particularly angry. It was something I knew I would hear eventually because I’d heard of others experiencing it,” Dr. Nayagan said in an interview. “Psychiatry is one of the fields of medicine that is often questioned in terms of legitimacy, and I knew that when I applied for psych residency,” she said.

Nevertheless, she wrote a post about the incident on Twitter, and she discovered she was far from alone. She posted her original tweet at the start of a night shift and was surprised by the number of responses when she opened her account the next day.

So far, Dr. Nayagan’s initial tweet has garnered 86 replies, 960 likes, and 35 retweets. Some clinicians reported similar experiences from both patients and colleagues, and others offered advice on how to handle such slights.

“There were a lot from people within mental health, but I also received responses from pathologists, radiologists, and others. I didn’t realize how much this experience pervaded through medicine, where a certain specialty would be told: You’re not a real doctor. So it was nice having that support,” Dr. Nayagan said.

Dr. Nayagan noted that psychiatrists encounter “specialty bias” to a greater extent than other medical professionals, and it can be a deterrent for medical students when considering psychiatry as a career path.

“It is something that has been around for a while, but it’s surprising that it’s still prevalent in 2020,” Dr. Nayagan said.
 

‘Busting the myth’

This type of bias is real, agreed Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences and vice chair for education at the University of Minnesota, Minneapolis, and former director of the psychiatry residency program at the school for 8 years.

She said there is “discrimination” toward psychiatrists, but noted that the problem is improving.

“I think we’re better now than 2 years or 5 years or 10 years ago, so we’re heading in the right direction. But there is this history of confusion about psychiatry and what it is and isn’t,” Dr. Nelson said in an interview.

“Psychiatrists have the same robust biomedical training as all specialties. They completed medical school and have this additional specialty and in some cases subspecialty training that is comprehensive of biology, psychology, and social components. We call that using a biopsychosocial model,” she said.

However, she noted that, when talking with students about the field of psychiatry, there’s an awareness “that perhaps we aren’t wearing a white coat” or a stethoscope around the neck.

“That gets translated as, You are giving up medicine – you got this medical training, and you’re not using it. And I have to bust that myth and convey that it really is a privilege to be able to integrate these aspects of knowledge and expertise. It’s in no way giving up medicine – we’re practicing medicine every single day,” said Dr. Nelson.
 

Remnants of stigma remain

Tristan Gorrindo, MD, deputy medical director and chief of the division of education at the American Psychiatric Association, noted “remnants of stigma” still occur.

“In my mind, it’s really a misunderstanding of the relationship between mental health and physical health,” Dr. Gorrindo said in an interview.

“There’s still this notion that holds over from an old belief that the mind and the body are separate. However, the contemporary thinking in most of modern medicine is that mental illness and physical illness are really one and the same, and they influence each other in a very dynamic way all the time,” he said.

“Psychiatrists stand in both worlds. They’re really the bridge to both the psychiatric and physical aspects,” he added.

Dr. Gorrindo agreed with Dr. Nelson that this understanding has become more prevalent during past few decades.

“Within society, it’s become much more acceptable for people to talk about their mental illness and seek treatment. In a way, shedding daylight on this issue has allowed psychiatry to step forward and demonstrate its value,” he said.

“I think over time we’re going to see that stigma or specialty bias become an anachronism that will fall by the wayside as we see psychiatry more broadly integrated and accepted within the entire house of medicine,” said Dr. Gorrindo.
 

Taking a toll

Although some responders on Twitter advised Dr. Nayagan and other psychiatrists to “educate with a smile” when faced with specialty discrimination, Dr. Nelson noted that it’s important to recognize that experiencing “microaggressions” takes a toll.

“Anytime you’re given a signal that you aren’t really a physician or you’re not doing a real job, whether it’s based on race, gender, ethnicity, or being a psychiatrist, there is a cost. I’d say, know what you’re doing and hold your head up high, but recognize that there’s a cost for which you may need community and support from colleagues,” she said.

“Together, our culture is changing, and the future is bright. But it’s a little bit of an oversimplification to say, ‘Just brush it off.’ We must recognize that there’s a burden that comes from those forms of exclusion,” Dr. Nelson concluded.

A version of this article first appeared on Medscape.com.

During a particularly hectic day, Janeni Nayagan, MD, a first-year resident in the department of psychiatry and behavioral health at Cooper University Hospital, Camden, N.J., was taken aback – but not surprised – by a patient’s comment.

In the middle of an emergent situation, she overheard a patient say that Dr. Nayagan wasn’t a “real doctor, she’s a psych doctor.”

“When it happened, I wasn’t particularly angry. It was something I knew I would hear eventually because I’d heard of others experiencing it,” Dr. Nayagan said in an interview. “Psychiatry is one of the fields of medicine that is often questioned in terms of legitimacy, and I knew that when I applied for psych residency,” she said.

Nevertheless, she wrote a post about the incident on Twitter, and she discovered she was far from alone. She posted her original tweet at the start of a night shift and was surprised by the number of responses when she opened her account the next day.

So far, Dr. Nayagan’s initial tweet has garnered 86 replies, 960 likes, and 35 retweets. Some clinicians reported similar experiences from both patients and colleagues, and others offered advice on how to handle such slights.

“There were a lot from people within mental health, but I also received responses from pathologists, radiologists, and others. I didn’t realize how much this experience pervaded through medicine, where a certain specialty would be told: You’re not a real doctor. So it was nice having that support,” Dr. Nayagan said.

Dr. Nayagan noted that psychiatrists encounter “specialty bias” to a greater extent than other medical professionals, and it can be a deterrent for medical students when considering psychiatry as a career path.

“It is something that has been around for a while, but it’s surprising that it’s still prevalent in 2020,” Dr. Nayagan said.
 

‘Busting the myth’

This type of bias is real, agreed Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences and vice chair for education at the University of Minnesota, Minneapolis, and former director of the psychiatry residency program at the school for 8 years.

She said there is “discrimination” toward psychiatrists, but noted that the problem is improving.

“I think we’re better now than 2 years or 5 years or 10 years ago, so we’re heading in the right direction. But there is this history of confusion about psychiatry and what it is and isn’t,” Dr. Nelson said in an interview.

“Psychiatrists have the same robust biomedical training as all specialties. They completed medical school and have this additional specialty and in some cases subspecialty training that is comprehensive of biology, psychology, and social components. We call that using a biopsychosocial model,” she said.

However, she noted that, when talking with students about the field of psychiatry, there’s an awareness “that perhaps we aren’t wearing a white coat” or a stethoscope around the neck.

“That gets translated as, You are giving up medicine – you got this medical training, and you’re not using it. And I have to bust that myth and convey that it really is a privilege to be able to integrate these aspects of knowledge and expertise. It’s in no way giving up medicine – we’re practicing medicine every single day,” said Dr. Nelson.
 

Remnants of stigma remain

Tristan Gorrindo, MD, deputy medical director and chief of the division of education at the American Psychiatric Association, noted “remnants of stigma” still occur.

“In my mind, it’s really a misunderstanding of the relationship between mental health and physical health,” Dr. Gorrindo said in an interview.

“There’s still this notion that holds over from an old belief that the mind and the body are separate. However, the contemporary thinking in most of modern medicine is that mental illness and physical illness are really one and the same, and they influence each other in a very dynamic way all the time,” he said.

“Psychiatrists stand in both worlds. They’re really the bridge to both the psychiatric and physical aspects,” he added.

Dr. Gorrindo agreed with Dr. Nelson that this understanding has become more prevalent during past few decades.

“Within society, it’s become much more acceptable for people to talk about their mental illness and seek treatment. In a way, shedding daylight on this issue has allowed psychiatry to step forward and demonstrate its value,” he said.

“I think over time we’re going to see that stigma or specialty bias become an anachronism that will fall by the wayside as we see psychiatry more broadly integrated and accepted within the entire house of medicine,” said Dr. Gorrindo.
 

Taking a toll

Although some responders on Twitter advised Dr. Nayagan and other psychiatrists to “educate with a smile” when faced with specialty discrimination, Dr. Nelson noted that it’s important to recognize that experiencing “microaggressions” takes a toll.

“Anytime you’re given a signal that you aren’t really a physician or you’re not doing a real job, whether it’s based on race, gender, ethnicity, or being a psychiatrist, there is a cost. I’d say, know what you’re doing and hold your head up high, but recognize that there’s a cost for which you may need community and support from colleagues,” she said.

“Together, our culture is changing, and the future is bright. But it’s a little bit of an oversimplification to say, ‘Just brush it off.’ We must recognize that there’s a burden that comes from those forms of exclusion,” Dr. Nelson concluded.

A version of this article first appeared on Medscape.com.

During a particularly hectic day, Janeni Nayagan, MD, a first-year resident in the department of psychiatry and behavioral health at Cooper University Hospital, Camden, N.J., was taken aback – but not surprised – by a patient’s comment.

In the middle of an emergent situation, she overheard a patient say that Dr. Nayagan wasn’t a “real doctor, she’s a psych doctor.”

“When it happened, I wasn’t particularly angry. It was something I knew I would hear eventually because I’d heard of others experiencing it,” Dr. Nayagan said in an interview. “Psychiatry is one of the fields of medicine that is often questioned in terms of legitimacy, and I knew that when I applied for psych residency,” she said.

Nevertheless, she wrote a post about the incident on Twitter, and she discovered she was far from alone. She posted her original tweet at the start of a night shift and was surprised by the number of responses when she opened her account the next day.

So far, Dr. Nayagan’s initial tweet has garnered 86 replies, 960 likes, and 35 retweets. Some clinicians reported similar experiences from both patients and colleagues, and others offered advice on how to handle such slights.

“There were a lot from people within mental health, but I also received responses from pathologists, radiologists, and others. I didn’t realize how much this experience pervaded through medicine, where a certain specialty would be told: You’re not a real doctor. So it was nice having that support,” Dr. Nayagan said.

Dr. Nayagan noted that psychiatrists encounter “specialty bias” to a greater extent than other medical professionals, and it can be a deterrent for medical students when considering psychiatry as a career path.

“It is something that has been around for a while, but it’s surprising that it’s still prevalent in 2020,” Dr. Nayagan said.
 

‘Busting the myth’

This type of bias is real, agreed Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences and vice chair for education at the University of Minnesota, Minneapolis, and former director of the psychiatry residency program at the school for 8 years.

She said there is “discrimination” toward psychiatrists, but noted that the problem is improving.

“I think we’re better now than 2 years or 5 years or 10 years ago, so we’re heading in the right direction. But there is this history of confusion about psychiatry and what it is and isn’t,” Dr. Nelson said in an interview.

“Psychiatrists have the same robust biomedical training as all specialties. They completed medical school and have this additional specialty and in some cases subspecialty training that is comprehensive of biology, psychology, and social components. We call that using a biopsychosocial model,” she said.

However, she noted that, when talking with students about the field of psychiatry, there’s an awareness “that perhaps we aren’t wearing a white coat” or a stethoscope around the neck.

“That gets translated as, You are giving up medicine – you got this medical training, and you’re not using it. And I have to bust that myth and convey that it really is a privilege to be able to integrate these aspects of knowledge and expertise. It’s in no way giving up medicine – we’re practicing medicine every single day,” said Dr. Nelson.
 

Remnants of stigma remain

Tristan Gorrindo, MD, deputy medical director and chief of the division of education at the American Psychiatric Association, noted “remnants of stigma” still occur.

“In my mind, it’s really a misunderstanding of the relationship between mental health and physical health,” Dr. Gorrindo said in an interview.

“There’s still this notion that holds over from an old belief that the mind and the body are separate. However, the contemporary thinking in most of modern medicine is that mental illness and physical illness are really one and the same, and they influence each other in a very dynamic way all the time,” he said.

“Psychiatrists stand in both worlds. They’re really the bridge to both the psychiatric and physical aspects,” he added.

Dr. Gorrindo agreed with Dr. Nelson that this understanding has become more prevalent during past few decades.

“Within society, it’s become much more acceptable for people to talk about their mental illness and seek treatment. In a way, shedding daylight on this issue has allowed psychiatry to step forward and demonstrate its value,” he said.

“I think over time we’re going to see that stigma or specialty bias become an anachronism that will fall by the wayside as we see psychiatry more broadly integrated and accepted within the entire house of medicine,” said Dr. Gorrindo.
 

Taking a toll

Although some responders on Twitter advised Dr. Nayagan and other psychiatrists to “educate with a smile” when faced with specialty discrimination, Dr. Nelson noted that it’s important to recognize that experiencing “microaggressions” takes a toll.

“Anytime you’re given a signal that you aren’t really a physician or you’re not doing a real job, whether it’s based on race, gender, ethnicity, or being a psychiatrist, there is a cost. I’d say, know what you’re doing and hold your head up high, but recognize that there’s a cost for which you may need community and support from colleagues,” she said.

“Together, our culture is changing, and the future is bright. But it’s a little bit of an oversimplification to say, ‘Just brush it off.’ We must recognize that there’s a burden that comes from those forms of exclusion,” Dr. Nelson concluded.

A version of this article first appeared on Medscape.com.

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

A version of this article first appeared on Medscape.com.

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

A version of this article first appeared on Medscape.com.

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

A version of this article first appeared on Medscape.com.

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

A version of this article first appeared on Medscape.com.

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

A version of this article first appeared on Medscape.com.

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

A version of this article first appeared on Medscape.com.

COVID-19 has thrown a wrench in standard treatment protocols for patients with chronic lymphocytic leukemia (CLL). These patients already face a greater risk of dying from infections, and recent research suggests they tend to have risk factors that increase their likelihood of complications and death from COVID-19.

In August, a group of oncologists from the United States and Europe published a literature-informed expert opinion to help their colleagues navigate this new CLL treatment landscape. It offers a roadmap for balancing patients’ therapeutic needs against their risk for viral infection and outlines the safest course of action for patients who test positive for COVID-19.

Mazyar Shadman, MD, MPH, an associate professor in the Clinical Research Division of the Fred Hutchinson Cancer Research Center and the Division of Medical Oncology at the University of Washington School of Medicine, in Seattle, Washington, was contacted for comment to break down what clinicians need to know about treating CLL during the pandemic. This interview has been edited for length and clarity.
 

Question: What prompted you and colleagues from the United States and Europe to write these recommendations?

Dr. Shadman: When we began the collaboration earlier this year, our colleagues in Italy and the rest of Europe had more experience with COVID-19, so they led the effort. We wanted to help oncologists manage their patients with CLL during the pandemic based on the evidence we had at the time and the unknowns we faced.
 

What’s an example of how the available evidence informed your recommendations?

At the time, we didn’t know whether patients with CLL were more likely to get COVID-19, compared to the general population, but we did have evidence already that cancer increases patients’ risk of bad outcomes and death from COVID-19. CLL, for example, can increase risk factors for infection, including hypogammaglobulinemia, innate immune dysfunction, and neutropenia, which may be exacerbated by anticancer treatments. Patients’ existing immune suppression might prevent or delay their ability to react to or cope with the virus. And many patients with CLL have other conditions that increase their risk of a severe response to COVID-19, including older age (70% of CLL patients are older than 65 years), hypertension (21%), and diabetes (26%).

These factors informed our recommendations to limit patients’ exposure to COVID-19 by reducing or postponing the number of in-person visits and routine in-hospital follow-ups, especially if they could be substituted with virtual check-ins.
 

The expert opinion recommendations are divided into three main categories: patients who are newly diagnosed with CLL but have not begun receiving therapy, those already receiving therapy but are free of COVID-19, and those who test positive for COVID-19. Let’s start with the first category. What do the recommendations say about waiting versus proceeding for newly diagnosed patients?

Our priority was balancing the negative impacts of getting COVID-19 with the negative impacts of postponing cancer treatment. We suggested taking each new CLL case on a patient-by-patient basis to determine who needed treatment tomorrow and who could wait a few weeks or months. Fortunately, CLL rarely requires immediate therapy, so the preference was to postpone treatment a few weeks, depending on the local COVID-19 outbreak situation.

In my practice, for instance, we tried to postpone visits as much as we could. Before the pandemic, patients with CLL in the watch-and-wait phase – those diagnosed but who don’t require treatment immediately – would come in for bloodwork and exams every 3-6 months. But when the pandemic hit, we skipped 3-month visits for patients with stable lab results and switched to telehealth visits instead. For those who needed blood draws, we used local labs closer to the patient’s home to minimize their exposure and transportation requirements.

When treatment cannot be deferred, we’ve recommended starting patients on therapies that require fewer in-person visits and are less immune suppressive. We recommended oncologists consider Bruton tyrosine kinase (BTK) inhibitors, such as ibrutinib and acalabrutinib, as well as venetoclax. Some research suggests these inhibitors may be protective against COVID-19 by blunting a patient’s hyperinflammatory response to the virus. These drugs also require minimal routine treatment and lab visits, which helps limit patients’ potential exposure to COVID-19.

But there are risks to waiting. Even during the peak of the pandemic here in Seattle, if patients needed treatment immediately, we did not delay. Patients with significant drops in their platelet or neutrophil count or those with bulky disease, for instance, do require therapy.

It’s important to mention that we did have bad experiences with patients who needed immediate treatment and their treating physicians decided to wait because of COVID-19 risks. These patients who came in with aggressive CLL and experienced delays in care had much more complicated CLL treatment than if they had started treatment earlier.

When organ function became abnormal, for example, some patients could no longer receive certain therapies. If someone’s kidney function becomes abnormal, I wouldn’t recommend giving a drug like venetoclax. Although rare, some patients on venetoclax develop tumor lysis syndrome, which can lead to kidney failure.

Bottom line: Don’t just assume it’s a low-grade disease and that you can wait.



What about patients already receiving treatment for CLL who are free of COVID-19?

For patients on active treatment, we suggested stopping or holding treatment with monoclonal antibodies, such as rituximab and obinutuzumab, and chemotherapy regimens, such as idelalisib plus rituximab and duvelisib, when possible. We recommended oncologists consider continuing treatment for patients on BTK inhibitors.



What happens if a patient with CLL tests positive for COVID-19?

If a patient tests positive for COVID-19 but is not yet on CLL treatment, we recommend postponing CLL care until they’ve recovered from the infection. If a patient is already receiving treatment, the recommendations are similar to those above for COVID-19–negative patients: Delay care for those on chemotherapy and monoclonal antibodies, but consider continuing treatment for patients on BTK inhibitors.
 

The expert opinion was submitted in May and ultimately published in August. How has our understanding of treating CLL during the pandemic changed since then? Would you change any recommendations?

When we published this paper, it was still early on in the pandemic, and we didn’t know as much about COVID-19 and CLL as we do now. Since we published the recommendations, we have received confirmation from several studies that patients with cancer have a more complicated course of COVID-19 and have worse outcomes. But I believe the recommendations we devised early in the pandemic still hold now. Decisions about delivering treatment should be influenced by the local COVID-19 numbers and hospital resources as well as the patient’s specific situation – whether they have more stable disease and can delay or postpone care or whether they need more immediate attention.

With a further surge in cases predicted as we move even deeper into flu season, what would you recommend for initiating treatment in newly diagnosed patients?

The pandemic has created a very fluid situation for treating CLL. What’s happening now in Seattle may not be the same story in New York, California, or elsewhere. In early November [when Dr. Shadman was first contacted], in Seattle, we were not postponing care because our COVID-19 numbers were fairly good. But, as of mid December, that is starting to change as the COVID-19 numbers fluctuate.
 

If we do experience a second peak of COVID-19 cases, we would need to modify our practice as we did during the initial surge earlier this year. That would mean avoiding treatment with monoclonal antibodies and chemotherapy, as well as minimizing blood draws and drugs that require frequent in-person visits.
 

How important is it for patients to be vaccinated against COVID-19?

There are two key things to consider about a vaccine. Is the vaccine safe from the general safety standpoint that everyone is worried about? And if the vaccine is not harmful, will it work in patients will CLL?

Because we don’t yet know the complete side-effect profile of a COVID-19 vaccine, we would need to assess each patient’s condition to limit adverse reactions and to see whether the vaccine alters a patient’s immune response to the CLL drug they’re taking.

At the University of Washington, Seattle, we have a plan to start studying the effectiveness of the Pfizer and Moderna vaccines in patients with CLL – carefully assessing patients’ response to the vaccine in terms of antibody response. We already know, based on small studies, that the antibody response to the flu vaccine, for instance, is not as strong in patients with CLL, compared to those without. But, overall, as long as the vaccine won’t cause harm, I would recommend my patients get it.

Dr. Shadman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COVID-19 has thrown a wrench in standard treatment protocols for patients with chronic lymphocytic leukemia (CLL). These patients already face a greater risk of dying from infections, and recent research suggests they tend to have risk factors that increase their likelihood of complications and death from COVID-19.

In August, a group of oncologists from the United States and Europe published a literature-informed expert opinion to help their colleagues navigate this new CLL treatment landscape. It offers a roadmap for balancing patients’ therapeutic needs against their risk for viral infection and outlines the safest course of action for patients who test positive for COVID-19.

Mazyar Shadman, MD, MPH, an associate professor in the Clinical Research Division of the Fred Hutchinson Cancer Research Center and the Division of Medical Oncology at the University of Washington School of Medicine, in Seattle, Washington, was contacted for comment to break down what clinicians need to know about treating CLL during the pandemic. This interview has been edited for length and clarity.
 

Question: What prompted you and colleagues from the United States and Europe to write these recommendations?

Dr. Shadman: When we began the collaboration earlier this year, our colleagues in Italy and the rest of Europe had more experience with COVID-19, so they led the effort. We wanted to help oncologists manage their patients with CLL during the pandemic based on the evidence we had at the time and the unknowns we faced.
 

What’s an example of how the available evidence informed your recommendations?

At the time, we didn’t know whether patients with CLL were more likely to get COVID-19, compared to the general population, but we did have evidence already that cancer increases patients’ risk of bad outcomes and death from COVID-19. CLL, for example, can increase risk factors for infection, including hypogammaglobulinemia, innate immune dysfunction, and neutropenia, which may be exacerbated by anticancer treatments. Patients’ existing immune suppression might prevent or delay their ability to react to or cope with the virus. And many patients with CLL have other conditions that increase their risk of a severe response to COVID-19, including older age (70% of CLL patients are older than 65 years), hypertension (21%), and diabetes (26%).

These factors informed our recommendations to limit patients’ exposure to COVID-19 by reducing or postponing the number of in-person visits and routine in-hospital follow-ups, especially if they could be substituted with virtual check-ins.
 

The expert opinion recommendations are divided into three main categories: patients who are newly diagnosed with CLL but have not begun receiving therapy, those already receiving therapy but are free of COVID-19, and those who test positive for COVID-19. Let’s start with the first category. What do the recommendations say about waiting versus proceeding for newly diagnosed patients?

Our priority was balancing the negative impacts of getting COVID-19 with the negative impacts of postponing cancer treatment. We suggested taking each new CLL case on a patient-by-patient basis to determine who needed treatment tomorrow and who could wait a few weeks or months. Fortunately, CLL rarely requires immediate therapy, so the preference was to postpone treatment a few weeks, depending on the local COVID-19 outbreak situation.

In my practice, for instance, we tried to postpone visits as much as we could. Before the pandemic, patients with CLL in the watch-and-wait phase – those diagnosed but who don’t require treatment immediately – would come in for bloodwork and exams every 3-6 months. But when the pandemic hit, we skipped 3-month visits for patients with stable lab results and switched to telehealth visits instead. For those who needed blood draws, we used local labs closer to the patient’s home to minimize their exposure and transportation requirements.

When treatment cannot be deferred, we’ve recommended starting patients on therapies that require fewer in-person visits and are less immune suppressive. We recommended oncologists consider Bruton tyrosine kinase (BTK) inhibitors, such as ibrutinib and acalabrutinib, as well as venetoclax. Some research suggests these inhibitors may be protective against COVID-19 by blunting a patient’s hyperinflammatory response to the virus. These drugs also require minimal routine treatment and lab visits, which helps limit patients’ potential exposure to COVID-19.

But there are risks to waiting. Even during the peak of the pandemic here in Seattle, if patients needed treatment immediately, we did not delay. Patients with significant drops in their platelet or neutrophil count or those with bulky disease, for instance, do require therapy.

It’s important to mention that we did have bad experiences with patients who needed immediate treatment and their treating physicians decided to wait because of COVID-19 risks. These patients who came in with aggressive CLL and experienced delays in care had much more complicated CLL treatment than if they had started treatment earlier.

When organ function became abnormal, for example, some patients could no longer receive certain therapies. If someone’s kidney function becomes abnormal, I wouldn’t recommend giving a drug like venetoclax. Although rare, some patients on venetoclax develop tumor lysis syndrome, which can lead to kidney failure.

Bottom line: Don’t just assume it’s a low-grade disease and that you can wait.



What about patients already receiving treatment for CLL who are free of COVID-19?

For patients on active treatment, we suggested stopping or holding treatment with monoclonal antibodies, such as rituximab and obinutuzumab, and chemotherapy regimens, such as idelalisib plus rituximab and duvelisib, when possible. We recommended oncologists consider continuing treatment for patients on BTK inhibitors.



What happens if a patient with CLL tests positive for COVID-19?

If a patient tests positive for COVID-19 but is not yet on CLL treatment, we recommend postponing CLL care until they’ve recovered from the infection. If a patient is already receiving treatment, the recommendations are similar to those above for COVID-19–negative patients: Delay care for those on chemotherapy and monoclonal antibodies, but consider continuing treatment for patients on BTK inhibitors.
 

The expert opinion was submitted in May and ultimately published in August. How has our understanding of treating CLL during the pandemic changed since then? Would you change any recommendations?

When we published this paper, it was still early on in the pandemic, and we didn’t know as much about COVID-19 and CLL as we do now. Since we published the recommendations, we have received confirmation from several studies that patients with cancer have a more complicated course of COVID-19 and have worse outcomes. But I believe the recommendations we devised early in the pandemic still hold now. Decisions about delivering treatment should be influenced by the local COVID-19 numbers and hospital resources as well as the patient’s specific situation – whether they have more stable disease and can delay or postpone care or whether they need more immediate attention.

With a further surge in cases predicted as we move even deeper into flu season, what would you recommend for initiating treatment in newly diagnosed patients?

The pandemic has created a very fluid situation for treating CLL. What’s happening now in Seattle may not be the same story in New York, California, or elsewhere. In early November [when Dr. Shadman was first contacted], in Seattle, we were not postponing care because our COVID-19 numbers were fairly good. But, as of mid December, that is starting to change as the COVID-19 numbers fluctuate.
 

If we do experience a second peak of COVID-19 cases, we would need to modify our practice as we did during the initial surge earlier this year. That would mean avoiding treatment with monoclonal antibodies and chemotherapy, as well as minimizing blood draws and drugs that require frequent in-person visits.
 

How important is it for patients to be vaccinated against COVID-19?

There are two key things to consider about a vaccine. Is the vaccine safe from the general safety standpoint that everyone is worried about? And if the vaccine is not harmful, will it work in patients will CLL?

Because we don’t yet know the complete side-effect profile of a COVID-19 vaccine, we would need to assess each patient’s condition to limit adverse reactions and to see whether the vaccine alters a patient’s immune response to the CLL drug they’re taking.

At the University of Washington, Seattle, we have a plan to start studying the effectiveness of the Pfizer and Moderna vaccines in patients with CLL – carefully assessing patients’ response to the vaccine in terms of antibody response. We already know, based on small studies, that the antibody response to the flu vaccine, for instance, is not as strong in patients with CLL, compared to those without. But, overall, as long as the vaccine won’t cause harm, I would recommend my patients get it.

Dr. Shadman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COVID-19 has thrown a wrench in standard treatment protocols for patients with chronic lymphocytic leukemia (CLL). These patients already face a greater risk of dying from infections, and recent research suggests they tend to have risk factors that increase their likelihood of complications and death from COVID-19.

In August, a group of oncologists from the United States and Europe published a literature-informed expert opinion to help their colleagues navigate this new CLL treatment landscape. It offers a roadmap for balancing patients’ therapeutic needs against their risk for viral infection and outlines the safest course of action for patients who test positive for COVID-19.

Mazyar Shadman, MD, MPH, an associate professor in the Clinical Research Division of the Fred Hutchinson Cancer Research Center and the Division of Medical Oncology at the University of Washington School of Medicine, in Seattle, Washington, was contacted for comment to break down what clinicians need to know about treating CLL during the pandemic. This interview has been edited for length and clarity.
 

Question: What prompted you and colleagues from the United States and Europe to write these recommendations?

Dr. Shadman: When we began the collaboration earlier this year, our colleagues in Italy and the rest of Europe had more experience with COVID-19, so they led the effort. We wanted to help oncologists manage their patients with CLL during the pandemic based on the evidence we had at the time and the unknowns we faced.
 

What’s an example of how the available evidence informed your recommendations?

At the time, we didn’t know whether patients with CLL were more likely to get COVID-19, compared to the general population, but we did have evidence already that cancer increases patients’ risk of bad outcomes and death from COVID-19. CLL, for example, can increase risk factors for infection, including hypogammaglobulinemia, innate immune dysfunction, and neutropenia, which may be exacerbated by anticancer treatments. Patients’ existing immune suppression might prevent or delay their ability to react to or cope with the virus. And many patients with CLL have other conditions that increase their risk of a severe response to COVID-19, including older age (70% of CLL patients are older than 65 years), hypertension (21%), and diabetes (26%).

These factors informed our recommendations to limit patients’ exposure to COVID-19 by reducing or postponing the number of in-person visits and routine in-hospital follow-ups, especially if they could be substituted with virtual check-ins.
 

The expert opinion recommendations are divided into three main categories: patients who are newly diagnosed with CLL but have not begun receiving therapy, those already receiving therapy but are free of COVID-19, and those who test positive for COVID-19. Let’s start with the first category. What do the recommendations say about waiting versus proceeding for newly diagnosed patients?

Our priority was balancing the negative impacts of getting COVID-19 with the negative impacts of postponing cancer treatment. We suggested taking each new CLL case on a patient-by-patient basis to determine who needed treatment tomorrow and who could wait a few weeks or months. Fortunately, CLL rarely requires immediate therapy, so the preference was to postpone treatment a few weeks, depending on the local COVID-19 outbreak situation.

In my practice, for instance, we tried to postpone visits as much as we could. Before the pandemic, patients with CLL in the watch-and-wait phase – those diagnosed but who don’t require treatment immediately – would come in for bloodwork and exams every 3-6 months. But when the pandemic hit, we skipped 3-month visits for patients with stable lab results and switched to telehealth visits instead. For those who needed blood draws, we used local labs closer to the patient’s home to minimize their exposure and transportation requirements.

When treatment cannot be deferred, we’ve recommended starting patients on therapies that require fewer in-person visits and are less immune suppressive. We recommended oncologists consider Bruton tyrosine kinase (BTK) inhibitors, such as ibrutinib and acalabrutinib, as well as venetoclax. Some research suggests these inhibitors may be protective against COVID-19 by blunting a patient’s hyperinflammatory response to the virus. These drugs also require minimal routine treatment and lab visits, which helps limit patients’ potential exposure to COVID-19.

But there are risks to waiting. Even during the peak of the pandemic here in Seattle, if patients needed treatment immediately, we did not delay. Patients with significant drops in their platelet or neutrophil count or those with bulky disease, for instance, do require therapy.

It’s important to mention that we did have bad experiences with patients who needed immediate treatment and their treating physicians decided to wait because of COVID-19 risks. These patients who came in with aggressive CLL and experienced delays in care had much more complicated CLL treatment than if they had started treatment earlier.

When organ function became abnormal, for example, some patients could no longer receive certain therapies. If someone’s kidney function becomes abnormal, I wouldn’t recommend giving a drug like venetoclax. Although rare, some patients on venetoclax develop tumor lysis syndrome, which can lead to kidney failure.

Bottom line: Don’t just assume it’s a low-grade disease and that you can wait.



What about patients already receiving treatment for CLL who are free of COVID-19?

For patients on active treatment, we suggested stopping or holding treatment with monoclonal antibodies, such as rituximab and obinutuzumab, and chemotherapy regimens, such as idelalisib plus rituximab and duvelisib, when possible. We recommended oncologists consider continuing treatment for patients on BTK inhibitors.



What happens if a patient with CLL tests positive for COVID-19?

If a patient tests positive for COVID-19 but is not yet on CLL treatment, we recommend postponing CLL care until they’ve recovered from the infection. If a patient is already receiving treatment, the recommendations are similar to those above for COVID-19–negative patients: Delay care for those on chemotherapy and monoclonal antibodies, but consider continuing treatment for patients on BTK inhibitors.
 

The expert opinion was submitted in May and ultimately published in August. How has our understanding of treating CLL during the pandemic changed since then? Would you change any recommendations?

When we published this paper, it was still early on in the pandemic, and we didn’t know as much about COVID-19 and CLL as we do now. Since we published the recommendations, we have received confirmation from several studies that patients with cancer have a more complicated course of COVID-19 and have worse outcomes. But I believe the recommendations we devised early in the pandemic still hold now. Decisions about delivering treatment should be influenced by the local COVID-19 numbers and hospital resources as well as the patient’s specific situation – whether they have more stable disease and can delay or postpone care or whether they need more immediate attention.

With a further surge in cases predicted as we move even deeper into flu season, what would you recommend for initiating treatment in newly diagnosed patients?

The pandemic has created a very fluid situation for treating CLL. What’s happening now in Seattle may not be the same story in New York, California, or elsewhere. In early November [when Dr. Shadman was first contacted], in Seattle, we were not postponing care because our COVID-19 numbers were fairly good. But, as of mid December, that is starting to change as the COVID-19 numbers fluctuate.
 

If we do experience a second peak of COVID-19 cases, we would need to modify our practice as we did during the initial surge earlier this year. That would mean avoiding treatment with monoclonal antibodies and chemotherapy, as well as minimizing blood draws and drugs that require frequent in-person visits.
 

How important is it for patients to be vaccinated against COVID-19?

There are two key things to consider about a vaccine. Is the vaccine safe from the general safety standpoint that everyone is worried about? And if the vaccine is not harmful, will it work in patients will CLL?

Because we don’t yet know the complete side-effect profile of a COVID-19 vaccine, we would need to assess each patient’s condition to limit adverse reactions and to see whether the vaccine alters a patient’s immune response to the CLL drug they’re taking.

At the University of Washington, Seattle, we have a plan to start studying the effectiveness of the Pfizer and Moderna vaccines in patients with CLL – carefully assessing patients’ response to the vaccine in terms of antibody response. We already know, based on small studies, that the antibody response to the flu vaccine, for instance, is not as strong in patients with CLL, compared to those without. But, overall, as long as the vaccine won’t cause harm, I would recommend my patients get it.

Dr. Shadman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

I have learned a lot about crisis management and leadership in the rapidly changing COVID health care environment. I have learned how to make quick and imperfect decisions with limited information, and how to move on swiftly. I have learned how to quickly fade out memories of how we used to run our business, and pivot to unknown and untested delivery modalities. I have learned how to take regulatory standards as guidance, not doctrine. And I have learned how tell longstanding loyal colleagues that they are being laid off.

Many of these leadership challenges are not new, but the rapidity of change and the weight and magnitude of decision making is unparalleled in my relatively short career. In some ways, it reminds me of some solid lessons I have learned over time as a lifetime runner, with many analogies and applications to leadership.

Some people ask me why I run. “You must get a runner’s high.” The truth is, I have never had a runner’s high. I feel every step. In fact, the very nature of running makes a person feel like they are being pulled under water. Runners are typically tachycardic and short of breath the whole time they are running. But what running does allow for is to ignore some of the signals your body is sending, and wholly and completely focus on other things. I often have my most creative and innovative thoughts while running. So that is why I run. But back to the point of what running and leadership have in common – and how lessons learned can translate between the two:

They are both really hard. As I mentioned above, running literally makes you feel like you are drowning. But when you finish running, it is amazing how easy everything else feels! Similar to leadership, it should feel hard, but not too hard. I have seen firsthand the effects of under- and over-delegating, and both are dysfunctional. Good leadership is a blend of being humble and servant, but also ensuring self-care and endurance. It is also important to acknowledge the difficulty of leadership. Dr. Tom Lee, currently chief medical officer at Press Ganey, is a leader I have always admired. He once said, “Leadership can be very lonely.” At the time, I did not quite understand that, but I have come to experience that feeling occasionally. The other aspect of leadership that I find really hard is that often, people’s anger is misdirected at leaders as a natural outlet for that anger. Part of being a leader is enduring such anger, gaining an understanding for it, and doing what you can to help people through it.

They both work better when you are restored. It sounds generic and cliché, but you can’t be a good runner or a good leader when you are totally depleted.

They both require efficiency. When I was running my first marathon, a complete stranger ran up beside me and started giving me advice. I thought it was sort of strange advice at the time, but it turned out to be sound and useful. He noticed my running pattern of “sticking to the road,” and he told me I should rather “run as the crow flies.” What he meant was to run in as straight of a line as possible, regardless of the road, to preserve energy and save steps. He recommended picking a point on the horizon and running toward that point as straight as possible. As he sped off ahead of me in the next mile, his parting words were, “You’ll thank me at mile 24…” To this day, I still use that tactic, which I find very steadying and calming during running. The same can be said for leadership; as you pick a point on the horizon, keep yourself and your team heading toward that point with intense focus, and before you realize it, you’ve reached your destination.

They both require having a goal. That same stranger who gave me advice on running efficiently also asked what my goal was. It caught me off guard a bit, as I realized my only goal was to finish. He encouraged me to make a goal for the run, which could serve as a motivator when the going got tough. This was another piece of lasting advice I have used for both running and for leadership.

They both can be endured by committing to continuous forward motion. Running and leadership both become psychologically much easier when you realize all you really have to do is maintain continuous forward motion. Some days require less effort than others, but I can always convince myself I am capable of some forward motion.

They both are easier if you don’t overthink things. When I first started in a leadership position, I would have moments of anxiety if I thought too hard about what I was responsible for. Similar to running, it works best if you don’t overthink what difficulties it may bring; rather, just put on your shoes and get going.

In the end, leading during COVID is like stepping onto a new trail. Despite the new terrain and foreign path, my prior training and trusty pair of sneakers – like my leadership skills and past experiences – will get me through this journey, one step at a time.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.

I have learned a lot about crisis management and leadership in the rapidly changing COVID health care environment. I have learned how to make quick and imperfect decisions with limited information, and how to move on swiftly. I have learned how to quickly fade out memories of how we used to run our business, and pivot to unknown and untested delivery modalities. I have learned how to take regulatory standards as guidance, not doctrine. And I have learned how tell longstanding loyal colleagues that they are being laid off.

Many of these leadership challenges are not new, but the rapidity of change and the weight and magnitude of decision making is unparalleled in my relatively short career. In some ways, it reminds me of some solid lessons I have learned over time as a lifetime runner, with many analogies and applications to leadership.

Some people ask me why I run. “You must get a runner’s high.” The truth is, I have never had a runner’s high. I feel every step. In fact, the very nature of running makes a person feel like they are being pulled under water. Runners are typically tachycardic and short of breath the whole time they are running. But what running does allow for is to ignore some of the signals your body is sending, and wholly and completely focus on other things. I often have my most creative and innovative thoughts while running. So that is why I run. But back to the point of what running and leadership have in common – and how lessons learned can translate between the two:

They are both really hard. As I mentioned above, running literally makes you feel like you are drowning. But when you finish running, it is amazing how easy everything else feels! Similar to leadership, it should feel hard, but not too hard. I have seen firsthand the effects of under- and over-delegating, and both are dysfunctional. Good leadership is a blend of being humble and servant, but also ensuring self-care and endurance. It is also important to acknowledge the difficulty of leadership. Dr. Tom Lee, currently chief medical officer at Press Ganey, is a leader I have always admired. He once said, “Leadership can be very lonely.” At the time, I did not quite understand that, but I have come to experience that feeling occasionally. The other aspect of leadership that I find really hard is that often, people’s anger is misdirected at leaders as a natural outlet for that anger. Part of being a leader is enduring such anger, gaining an understanding for it, and doing what you can to help people through it.

They both work better when you are restored. It sounds generic and cliché, but you can’t be a good runner or a good leader when you are totally depleted.

They both require efficiency. When I was running my first marathon, a complete stranger ran up beside me and started giving me advice. I thought it was sort of strange advice at the time, but it turned out to be sound and useful. He noticed my running pattern of “sticking to the road,” and he told me I should rather “run as the crow flies.” What he meant was to run in as straight of a line as possible, regardless of the road, to preserve energy and save steps. He recommended picking a point on the horizon and running toward that point as straight as possible. As he sped off ahead of me in the next mile, his parting words were, “You’ll thank me at mile 24…” To this day, I still use that tactic, which I find very steadying and calming during running. The same can be said for leadership; as you pick a point on the horizon, keep yourself and your team heading toward that point with intense focus, and before you realize it, you’ve reached your destination.

They both require having a goal. That same stranger who gave me advice on running efficiently also asked what my goal was. It caught me off guard a bit, as I realized my only goal was to finish. He encouraged me to make a goal for the run, which could serve as a motivator when the going got tough. This was another piece of lasting advice I have used for both running and for leadership.

They both can be endured by committing to continuous forward motion. Running and leadership both become psychologically much easier when you realize all you really have to do is maintain continuous forward motion. Some days require less effort than others, but I can always convince myself I am capable of some forward motion.

They both are easier if you don’t overthink things. When I first started in a leadership position, I would have moments of anxiety if I thought too hard about what I was responsible for. Similar to running, it works best if you don’t overthink what difficulties it may bring; rather, just put on your shoes and get going.

In the end, leading during COVID is like stepping onto a new trail. Despite the new terrain and foreign path, my prior training and trusty pair of sneakers – like my leadership skills and past experiences – will get me through this journey, one step at a time.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.

I have learned a lot about crisis management and leadership in the rapidly changing COVID health care environment. I have learned how to make quick and imperfect decisions with limited information, and how to move on swiftly. I have learned how to quickly fade out memories of how we used to run our business, and pivot to unknown and untested delivery modalities. I have learned how to take regulatory standards as guidance, not doctrine. And I have learned how tell longstanding loyal colleagues that they are being laid off.

Many of these leadership challenges are not new, but the rapidity of change and the weight and magnitude of decision making is unparalleled in my relatively short career. In some ways, it reminds me of some solid lessons I have learned over time as a lifetime runner, with many analogies and applications to leadership.

Some people ask me why I run. “You must get a runner’s high.” The truth is, I have never had a runner’s high. I feel every step. In fact, the very nature of running makes a person feel like they are being pulled under water. Runners are typically tachycardic and short of breath the whole time they are running. But what running does allow for is to ignore some of the signals your body is sending, and wholly and completely focus on other things. I often have my most creative and innovative thoughts while running. So that is why I run. But back to the point of what running and leadership have in common – and how lessons learned can translate between the two:

They are both really hard. As I mentioned above, running literally makes you feel like you are drowning. But when you finish running, it is amazing how easy everything else feels! Similar to leadership, it should feel hard, but not too hard. I have seen firsthand the effects of under- and over-delegating, and both are dysfunctional. Good leadership is a blend of being humble and servant, but also ensuring self-care and endurance. It is also important to acknowledge the difficulty of leadership. Dr. Tom Lee, currently chief medical officer at Press Ganey, is a leader I have always admired. He once said, “Leadership can be very lonely.” At the time, I did not quite understand that, but I have come to experience that feeling occasionally. The other aspect of leadership that I find really hard is that often, people’s anger is misdirected at leaders as a natural outlet for that anger. Part of being a leader is enduring such anger, gaining an understanding for it, and doing what you can to help people through it.

They both work better when you are restored. It sounds generic and cliché, but you can’t be a good runner or a good leader when you are totally depleted.

They both require efficiency. When I was running my first marathon, a complete stranger ran up beside me and started giving me advice. I thought it was sort of strange advice at the time, but it turned out to be sound and useful. He noticed my running pattern of “sticking to the road,” and he told me I should rather “run as the crow flies.” What he meant was to run in as straight of a line as possible, regardless of the road, to preserve energy and save steps. He recommended picking a point on the horizon and running toward that point as straight as possible. As he sped off ahead of me in the next mile, his parting words were, “You’ll thank me at mile 24…” To this day, I still use that tactic, which I find very steadying and calming during running. The same can be said for leadership; as you pick a point on the horizon, keep yourself and your team heading toward that point with intense focus, and before you realize it, you’ve reached your destination.

They both require having a goal. That same stranger who gave me advice on running efficiently also asked what my goal was. It caught me off guard a bit, as I realized my only goal was to finish. He encouraged me to make a goal for the run, which could serve as a motivator when the going got tough. This was another piece of lasting advice I have used for both running and for leadership.

They both can be endured by committing to continuous forward motion. Running and leadership both become psychologically much easier when you realize all you really have to do is maintain continuous forward motion. Some days require less effort than others, but I can always convince myself I am capable of some forward motion.

They both are easier if you don’t overthink things. When I first started in a leadership position, I would have moments of anxiety if I thought too hard about what I was responsible for. Similar to running, it works best if you don’t overthink what difficulties it may bring; rather, just put on your shoes and get going.

In the end, leading during COVID is like stepping onto a new trail. Despite the new terrain and foreign path, my prior training and trusty pair of sneakers – like my leadership skills and past experiences – will get me through this journey, one step at a time.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.